Oral dextrose gel to prevent hypoglycaemia in at‐risk neonates
Abstract
Background
Neonatal hypoglycaemia is a common condition that can be associated with brain injury. Current practice usually includes early identification of at‐risk infants (e.g. infants of diabetic mothers; preterm, small‐ or large‐for‐gestational‐age infants), and prophylactic measures are advised. However, these measures often involve use of formula milk or admission to the neonatal unit. Dextrose gel is non‐invasive, inexpensive, and effective for treatment of neonatal hypoglycaemia. Use of prophylactic dextrose gel can prevent neonatal hypoglycaemia, thus potentially reducing separation of mother and baby and supporting breastfeeding, as well as preventing brain injury.
Objectives
To assess the effectiveness and safety of oral dextrose gel in preventing hypoglycaemia among newborn infants at risk of hypoglycaemia and in reducing long‐term neurodevelopmental impairment.
Search methods
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 12), MEDLINE via PubMed (1966 to 23 January 2017), Embase (1980 to 23 January 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 23 January 2017). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi‐randomised trials.
Selection criteria
We included randomised and quasi‐randomised studies comparing dextrose gel versus placebo, no intervention, or other therapies for prevention of neonatal hypoglycaemia.
Data collection and analysis
We used standard methodological procedures as expected by the Cochrane Collaboration. Two review authors independently assessed trial quality and extracted data. We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to assess the quality of evidence.
Main results
We included one trial comparing oral dextrose gel versus placebo in 416 infants at risk of hypoglycaemia. We judged this trial to be at low risk of bias. Using the GRADE method, we determined that evidence ranged from high quality to moderate quality.
For outcomes selected for the GRADE analysis, we found the following.
• Oral dextrose gel prophylaxis (any dose) is associated with reduced risk of neonatal hypoglycaemia compared with placebo (risk ratio (RR) 0.76, 95% confidence interval (CI) 0.62 to 0.94; one RCT; n = 415 infants; high‐quality evidence). The risk difference (RD) is ‐0.13 (95% CI ‐0.23 to ‐0.03), and on average, 8.3 infants would have to receive prophylactic dextrose gel to prevent one additional case of neonatal hypoglycaemia.
• Investigators found no statistically significant differences between dextrose gel and placebo groups in the number of adverse events (RR 1.09, 95% CI 0.55 to 2.17; one RCT; n = 413 infants; moderate‐quality evidence); separation from mother for treatment of hypoglycaemia (RR 0.46, 95% CI 0.21 to 1.01; one RCT, n = 415 infants; moderate‐quality evidence); exclusive breastfeeding at discharge (RR 1.00, 95% CI 0.86 to 1.15; one RCT; n = 415 women; moderate‐quality evidence); or breastfeeding at six weeks postpartum (RR 1.06, 95% CI 0.88 to 1.29; one RCT; n = 386 women; moderate‐quality evidence).
• Researchers provided no data for the other prespecified GRADE outcomes for this review (major neurological disability at two years of age or older; receipt of treatment for hypoglycaemia during initial hospital stay; receipt of intravenous treatment for hypoglycaemia).
Authors' conclusions
Oral dextrose gel reduced the risk of neonatal hypoglycaemia in at‐risk infants in a single trial. Results showed no statistically significant differences in the number of adverse events or in risk of separation of infant from mother for treatment of hypoglycaemia between babies who received oral dextrose gel and those given placebo. Caution is suggested in interpreting data for the latter two outcomes owing to low event rates.
Available evidence is limited to a cohort of at‐risk infants, most of whom were infants of diabetic mothers and were treated on the postnatal ward. Minimal data available for many of the prespecified outcomes of this review showed no long‐term neurodevelopmental and disability outcomes. Additional evidence is needed to assess the efficacy and safety of dextrose gel for prevention of neonatal hypoglycaemia.
PICOs
Plain language summary
Oral dextrose gel for prevention of low blood glucose levels in newborn babies
What is the issue?
Low blood glucose levels are common among newborn babies. Up to 15 of every 100 babies will have low blood glucose levels, and among some babies at higher risk (babies who are born preterm, or smaller or larger than most babies, or whose mothers are diabetic), as many as half will have low blood glucose levels over the first few days after they are born.
Why is this important?
Low blood glucose levels can cause problems with academic achievement and development during childhood. It is possible that even one low level can contribute to these problems in some babies. Therefore, it would be useful to prevent low blood glucose levels from happening. Additionally, treatments for low blood glucose levels often include formula milk or admission to the neonatal unit, leading to separation of mother and baby, and both of these approaches may impair breastfeeding.
What evidence did we find?
During searches updated to January 2017, we found one study (with low risk of bias) that compared oral dextrose gel versus placebo for prevention of low blood glucose levels in 415 at‐risk babies. Evidence from this single study suggests that in babies at risk, oral dextrose gel followed by a feed is associated with reduced risk of low blood glucose levels when compared with placebo (high‐quality evidence). Results showed no statistically significant differences between oral dextrose gel and placebo in terms of the number of adverse events (moderate‐quality evidence), risk of separation of baby from mother for treatment of low glucose levels (moderate‐quality evidence), exclusive breastfeeding at discharge (moderate‐quality evidence), or continued breastfeeding at six weeks of age (moderate‐quality evidence). We must be careful when interpreting the evidence for adverse events and separation of mother and baby, as a small number of events have been reported for these outcomes. Researchers provided no data on long‐term outcomes including developmental and disability outcomes.
What does this mean?
Available evidence came from only one study, and no long‐term outcome data have been reported. Additionally, this study considers only oral dextrose gel compared with placebo and does not consider other measures that could potentially prevent hypoglycaemia. Therefore, not enough evidence is available at this time to support the routine use of oral dextrose gel for prevention of hypoglycaemia in newborn babies at risk. Childhood follow‐up of the single study included here is under way, and an additional ongoing study is seeking to determine the effect of oral dextrose gel on preventing admission to the neonatal intensive care unit (NICU). We advise waiting for data on outcomes of these additional studies to assess the longer‐term safety and efficacy of oral dextrose gel for prevention of neonatal hypoglycaemia.
